In 2011, Ambrosi Scientific Consulting, FCBA, and Phycher Bio Development decided to share their areas of expertise to offer a comprehensive scientific and regulatory support in the field of biocides.
In accordance with the Biocidal Products Regulation (BPR, Regulation No.528/2012 ), active substances must be approved and authorisations are required to place biocidal products on the market; a complete data package must be submitted to the relevant Authorities, with a broad range of supporting studies and trials.
With the strength of our partnership, we can provide a global service to help you to obtain an active substance approval, or national and Union authorisations of biocidal products.
Our offer includes:
- Analysing your products portfolio to estimate the costs and timelines for preparing application dossiers
- Conducting and monitoring different types of studies under Good Laboratory Practice (G.L.P.)
- Preparing your entire application dossiers (and applications for mutual recognitions) and submitting them to the relevant Authorities.
- Managing requests from the Authorities during the evaluation time, until the active substance is approved or the biocidal product is authorised.
- We are committed to meet your specific needs and deliver high-quality services.
To help you remember some of the deadlines for the submission of application dossiers, here is an update regarding PT08 and PT18 active substances .
Please feel free to contact us for additional information.